CORE--HUMAN STUDIES

CURE一直处于胃肠道研究的最前沿，并且能够将基本的细胞进展转化为胃肠道疾病患者的人体研究。胃肠道疾病的重要性和意义突出表现在其对生活质量和医疗保健服务需求的全国影响。在此背景下，CURE：消化系统疾病研究核心中心（CURE：DDRCC）人类研究核心的使命是为CURE：DDRCC研究人员、受训人员及其合作者提供共享资源、人员、服务、教育和咨询，以研究患有选定消化系统疾病的患者。该核心的主要目标是促进合作，教育， 在选定的消化系统疾病中进行GI临床、人体生理学研究、转化和健康结局研究。虽然该中心的传统重点是消化系统疾病及其病理生理学的研究，但在上次拨款申请中，重点已经扩大到包括其他胃肠道疾病的研究，如胃食管反流病（GERD），非溃疡性消化不良，肠易激综合征（IBS），幽门螺杆菌感染，胃肠道出血和癌前病变（慢性胃炎和巴雷特上皮）。在上一个资助期间，对以下方面的兴趣和重视程度大幅增加：1）恶性前肠疾病和过程; 2）卫生服务研究; 3）人类研究核心研究人员和CURE基础科学研究人员之间的跨学科研究项目启动：DDRCC， 强调中心研究的转化性质; 4）年轻研究者或学员的职业发展和指导，以培养下一代以患者为导向的研究者。如下文第五节（对用户的惠益）和第七节（教育惠益）所示，这项工作非常成功。本核心的具体目的是为CURE：DDRCC成员、受训人员及其合作者提供：（1）一个高质量的临床研究单位（CRC），以低成本开展GI临床研究，该单位位于CURE-VA，不存在用于研究选定GI疾病的类似临床研究单位;（2）利用设备齐全的内窥镜检查和门诊CRC单位进行GI临床、生理和转化研究;（3）提供GI分泌试验、GI动力和动态pH值试验的实验室服务; pylori评估（C13尿素呼气试验）;（4）临床研究技术的教学和研究设计，数据管理，统计分析和常规咨询 成果;（5）选定胃肠道疾病患者的组织和临床数据库（最大的数据库是巴雷特上皮、GI出血、胶囊内镜-小肠疾病、GI癌症、粘膜炎性疾病-AIDS和IBD以及功能性GI疾病）;（6）就开展健康成果研究进行咨询，包括研究设计、成本评估、生活质量工具，以及建模或成本效益研究;（7）用于GI研究的专门设备（例如用于研究小肠运动和形态障碍的胶囊式内窥镜和用于研究GI癌症的内窥镜超声 （8）胃肠道动力实验室，用于研究胃食管反流病和神经内脏疾病。这些服务和程序所需的仪器、配件和人员都很昂贵，因此在核心中的各个研究者之间共享它们是成本效益高的，并促进了协作。

CURE has always been on the forefront of gastrointestinal research, and it has been uniquely able to translate basic cellular advances into human studies in patients with gastrointestinal diseases. The importance and significance of GI disorders is highlighted by their national impact on quality of life and demand for health care services. In this context, the mission of the Human Studies Core of the CURE: Digestive Disease Research Core Center (CURE: DDRCC) is to provide shared resources, personnel, services, education, and consultation to CURE: DDRCC investigators, trainees, and their collaborators for the study of patients with selected digestive disorders. The primary goal of this Core is to facilitate collaboration, education about, and performance of GI clinical, human physiological studies, translational, and health outcomes studies in selected digestive disorders. Whereas the traditional focus of the center was investigation of peptic disorders and their pathophysiology, the focus was previously broadened in the last grant application to include the study of other gastrointestinal disorders such as gastroesophageal reflux disease (GERD), nonulcer dyspepsia, irritable bowel syndrome (IBS), Helicobacter pylori infection, gastrointestinal hemorrhage, and pre-cancerous conditions (chronic gastritis and Barrett's epithelium). During the last funding period, there has been a substantial increase in interest and emphasis on: 1) malignant foregut conditions and processes; 2) health services research; 3) initiation of interdisciplinary research projects among investigators of the Human Studies Core and basic science investigators of CURE: DDRCC, emphasizing the translational nature of research at the Center; 4) career development and mentoring of young investigators or trainees to develop the next generation of patient-oriented investigators. This has been very successful as shown below, Section V (Benefits to users) and VII, Educational Benefits. The specific purposes of this Core are to provide CURE: DDRCC members, trainees, and their collaborators with access to: (1) a quality clinical research unit (CRC) for performance of GI clinical research at a low cost, based at CURE-VA where no similar clinical research unit exists for the study of selected GI disorders; (2) utilization of fully equipped endoscopy and outpatient CRC units for GI clinical, physiologic, and translational research studies;, (3) laboratory services for GI secretory tests, GI motility and ambulatory pH testing, and H. pylori assessments (C 13 urea breath test);, (4) teaching of clinical research techniques and consultation about study design, data management, statistical analysis, and routine outcomes; (5) tissue and clinical data banks of patients with selected GI diseases (the largest data bases are for Barrett's epithelium, GI hemorrhage, capsule endoscopy-small bowel disorders, GI cancers, mucosal inflammatory diseases-AIDS and IBD, and functional GI disease); (6) consultation about conducting health outcomes research, including design of studies, cost assessments, quality of life instruments, and modeling or cost-effectiveness studies; (7) specialized equipment for GI studies (such as capsule endoscopy for studying small bowel motility and morphology disorders and endoscopic ultrasound for study of GI cancers and tissue through translational or collaborative research); (8) GI motility laboratory for the study of GERD and neurovisceral diseases. The instruments, accessories, and personnel required for these services and procedures are expensive, so that sharing them among various investigators in a Core is cost effective and promotes collaboration.